Medicine
Clozapine 25 mg orally disintegrating tablet
Clozapine 25 mg orally disintegrating tablet is a generic prescription medicine for oral use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT)…
Key facts
- Active ingredient (INN)
- Clozapine
- Brand
- Sold under the generic name
- Strength
- 25 mg
- Dosage form
- Orally disintegrating tablet
- Route
- Oral
- Packs
- 100 tablets, 8 blister pack, 48 blister pack and 2 more
- Manufacturers
- Aurobindo PharmaIndiaTeva PharmaceuticalsMylan Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) at 20° to 25°C (68° to 77°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05AH02 Clozapine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 November 2015
- Identifiers
- RxCUI 476177, 476179, 721773 +2DailyMed set ID caf2d4a6-2a23-4992-a807-560c4204afc4, 9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219, 6fccf4f7-2e30-4272-9800-225aaef20584NDC 59651-261, 0378-3813, 0093-5417Application ANDA212923, ANDA201824, ANDA090308
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, orally disintegrating in 1 bottle | 59651-261-01 | Aurobindo PharmaIndia | 12 December 2024 |
| 8 blister pack in 1 carton / 6 tablet, orally disintegrating in 1 blister pack | 59651-261-48 | Aurobindo PharmaIndia | 12 December 2024 |
| 100 tablet, orally disintegrating in 1 bottle, plastic | 0378-3813-01 | Mylan Pharmaceuticals | 2 November 2015 |
| 100 tablet, orally disintegrating in 1 bottle | 0093-5417-01 | Teva Pharmaceuticals | 25 July 2017 |
| 48 blister pack in 1 carton / 1 tablet, orally disintegrating in 1 blister pack | 0093-5417-84 | Teva Pharmaceuticals | 25 July 2017 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 26 September 1989 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Clozapine
Clinical summary
Clozapine is an atypical antipsychotic indicated for treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment, among other approved uses. MedsAcross supplies Clozapine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about ClozapineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Clozaril prescribing information (HLS Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Clozapine 25 mg orally disintegrating tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.